Reviewer will perform primarily review of the day-to-day analytical testing data and related quality documents. The Reviewer may execute 90% - 100% of their work at the analytical data and/or documents.
- Review of day-to-day Analytical data generated in the Laboratory. Maintains and up dates essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.
- Serves as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities of other chemists. Participates in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest.
- Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and/or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
- Demonstrates critical thinking skills and creativity when solving problems. Originates reports in written or oral form so that new ideas or approaches are brought to the attention of appropriate personnel.
- Participate periodically internal audits compliance to cGLP and cGMP in Analytical Lab.
- Compilation and trending of Analytical data.
- Review and preparation of SOPs, STPs, GTPs and Protocols.
- Review/ approval of sample login in LIMS and data migration
OTHER FUNCTIONS AND RESPONSIBILITIES
Perform other duties as assigned
- Minimum BS with Scientific field
- BS with Chemistry is one of the subjects would be preferable
- Minimum 5 or more years experience in pharmaceutical analytical lab and 1-2 experience in reviewing QC data.
- Experience in Generic Pharmaceutical industries would be preferable
- Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
- Ability to learn quickly and decision making skills